Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome

NCT06271811 | Completed

• 1 other identifier: UJAPFPS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the efficacy of adding flossing band therapy to conventional physiotherapy in patients diagnosed with Patellofemoral Pain Syndrome (PFPS). The main questions it aims to answer are:

• Does combining flossing band therapy with conventional physiotherapy lead to greater improvements in pain, strength, and function compared to conventional physiotherapy alone?
• What are the effects of flossing band therapy on knee functionality and muscle strength in PFPS patients? Participants will be randomly assigned to either the Standard Physiotherapy group or the Flossing Band and Physiotherapy group. In addition to conventional physiotherapy, participants in the Flossing Band group will undergo sessions where a flossing band is applied around the knee joint to provide moderate compression. Researchers will compare the two groups to determine if the addition of flossing band therapy enhances treatment outcomes for PFPS.

Conditions

Anterior Knee Pain Syndrome; Patellofemoral Pain Syndrome

Keywords

Patellofemoral Pain Syndrome; physiotherapy; mind-body; flossing band

Outcome Measures

Primary Outcomes (3)

• Disability related to patellofemoral pain

  The Kujala Anterior Knee Pain Scale was employed to assess this variable. is a well-established tool used to evaluate symptoms and functional limitations in individuals with patellofemoral pain syndrome. This self-reported questionnaire comprises 13 items, each rated to provide a total score ranging from 0 to 100, where higher scores denote better knee function and fewer symptoms. While specific cut-off points are not universally defined, scores closer to 100 generally indicate minimal patellofemoral issues.

  From baseline to 8 weeks

• Knee extensor muscle strength

  In addition to isokinetic variables assessed with the Biodex System 4 dynamometer, manual handheld dynamometry was employed to measure knee extensor muscle strength, providing a comprehensive evaluation of muscle function in individuals with Patellofemoral Pain Syndrome.

  From baseline to 8 weeks

• Pain report

  Pain was measured using a visual analogue scale (VAS). The VAS consists of a 10-cm line, with the left extremity representing (the absence of pain) and the right extremity indicating (the worse pain devisable). Participants were asked to indicate on the scale their current level of pain being higher values related to more intense pain.

  From baseline to 8 weeks

Secondary Outcomes (6)

• Self-reported function

  From baseline to 8 weeks

• Short Form-36 (SF-36)

  From baseline to 8 weeks

• Berg Balance Scale (BBS)

  From baseline to 8 weeks

• Pittsburgh Sleep Quality Index

  From baseline to 8 weeks

• Brief Pain Questionnaire

  From baseline to 8 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

The intervention protocol is centered on neuromuscular training, targeting the strengthening of key muscle groups including the quadriceps, hamstrings, and hip abductors, which are vital for knee stabilization. This approach is supported by previous research, emphasizing the importance of these muscle groups in knee joint health. Complementing this, proprioceptive exercises, such as single-leg balances and controlled knee bends, were incorporated to enhance joint position sense, aligning with the guidelines set forth by Powers et al., 2010. The intensity of these exercises is progressively increased, tailored to each patient's tolerance and improvement. The protocol stipulates two sessions per week over eight weeks.

Other: Conventional physiotherapy

Intervention group

EXPERIMENTAL

The application of flossing to the knee commences with a preliminary evaluation of the joint range of motion and pain perception. The band is wrapped around the knee, starting with an approximate tension of 50% for the first wrap and escalating to a tension of 60-80% in subsequent wraps. It is essential to overlap the band with each wrap, moving from a distal to the proximal direction (bottom to top), which aids in enhancing drainage. Continuous monitoring of the patient is critical to ensure that excessive pressure is not being applied. This can be achieved by palpating the pulse on the dorsum of the foot or inner ankle, and observing if the skin regains its normal color after pressing the area with fingers. Should the patient experience strong tingling or pain, the bandage must be immediately removed. The duration of the band's application varies between 2 to 5 minutes, depending on patient tolerance, a methodology informed by existing research.

Procedure: Flossing band

Interventions

Flossing band PROCEDURE

The application of flossing to the knee commences with a preliminary evaluation of the joint range of motion and pain perception. The band is wrapped around the knee, starting with an approximate tension of 50% for the first wrap and escalating to a tension of 60-80% in subsequent wraps. It\'s essential to overlap the band with each wrap, moving from a distal to the proximal direction (bottom to top), which aids in enhancing drainage. Continuous monitoring of the patient is critical to ensure that excessive pressure is not being applied. This can be achieved by palpating the pulse on the dorsum of the foot or inner ankle, and observing if the skin regains its normal color after pressing the area with fingers. Should the patient experience strong tingling or pain, the bandage must be immediately removed. The duration of the band's application varies between 2 to 5 minutes, depending on patient tolerance, a methodology informed by existing research.

Intervention group

Conventional physiotherapy OTHER

The intervention protocol is centered on neuromuscular training, targeting the strengthening of key muscle groups including the quadriceps, hamstrings, and hip abductors, which are vital for knee stabilization. This approach is supported by previous research, emphasizing the importance of these muscle groups in knee joint health. Complementing this, proprioceptive exercises, such as single-leg balances and controlled knee bends, were incorporated to enhance joint position sense, aligning with the guidelines set forth by Powers et al., 2010. The intensity of these exercises is progressively increased, tailored to each patient's tolerance and improvement. The protocol stipulates two sessions per week over eight weeks.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A clinical diagnosis of Patellofemoral Pain Syndrome or patellofemoral misalignment, as confirmed by clinical signs and/or imaging studies (e.g., knee CT scans).
• An age range of 18 to 50 years, to include a broad spectrum of the population affected by PFPS.
• Experience retro patellar pain for at least three months, including pain at rest or during activities such as ascending or descending stairs, jumping, running, squatting, kneeling, or prolonged sitting.
• Pain or apprehension upon mobilization of the patella, and/or crepitus accompanied by pain during activities like squats.
• No history of medical treatment, physiotherapy specifically targeting PFPS, or lower extremity surgery within the last six months.

You may not qualify if:

• A history of significant lower extremity, pelvic, or spinal surgery/fracture, or traumatic lesions of ligaments or meniscus within the past six months.
• Presence of other orthopedic conditions (e.g., ligament rupture, meniscal tears), neurological disorders (e.g., multiple sclerosis, paralysis), rheumatological diseases (e.g., rheumatoid arthritis, ankylosing spondylitis), or congenital conditions leading to osteoarthrosis.
• Current pregnancy.
• A history of connective tissue disease, patellofemoral dislocation or subluxation, or osteoarthrosis of the knees.
• Use of sedatives or muscle relaxants that may alter muscle tone.
• Other forms of anterior knee pain (e.g., Osgood-Schlatter disease, tendon pain, bursitis).
• A history of referred pain from the lumbar spine.

Sponsors & Collaborators

• University of Jaén: lead
• University of Jaen: collaborator

Study Sites (1)

University of Jaen

Jaén, 23009, Spain

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• David Cruz Diaz, PhD

  University of Jaén

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: January 9, 2023
• Primary Completion: November 14, 2023
• Study Completion: November 20, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)